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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K IMPLANT; COCHLEAR IMPLANT
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ADVANCED BIONICS, LLC HIRES 90K IMPLANT; COCHLEAR IMPLANT Back to Search Results
Model Number CI-1400-01
Device Problems Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Irritation (1941); Skin Inflammation/ Irritation (4545)
Event Type  Injury  
Event Description
The recipient is reportedly experiencing retention issues and irritation at the implant site due to prolonged use of incorrectly fitting device equipment.The recipient is presenting with redness.The recipient is advised to discontinue device use for two weeks and to clean the area and apply a topical antibiotic cream.
 
Manufacturer Narrative
Advanced bionics considers the investigation into this reportable event as closed.The recipient's issues have reportedly resolved.The recipient resumed device use.Additional treatment details will not be provided.This is the final report.Disclaimer: advanced bionics does not intend that this report be any admission of liability, fault or product defect.
 
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Brand Name
HIRES 90K IMPLANT
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
MDR Report Key11324018
MDR Text Key231693099
Report Number3006556115-2021-00151
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 01/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/30/2013
Device Model NumberCI-1400-01
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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